MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11060A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Cardiac Tamponade (2226)

Event Date 07/12/2021

Event Type  Death  

Manufacturer Narrative

Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.At this time, the device has not been provided for evaluation.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported and discovered through medical records that a patient with a 23mm 11060a aortic valved conduit implanted for one (1) month 8 days was explanted due to dehiscence and bleeding at the at proximal anastomosis.The patient presented with chest pain and pericardial tamponade.The indication for the index procedure was a type a thoracoabdominal dissection.A 25mm 11500a aortic valve sewn into a non edward graft, and the pulmonary artery tear caused by dehiscence was repaired successfully.The valve was well functioning.The patient was returned to the icu in critical condition, but stable condition.The post operative course was complicated by: hit, multiple organ failure, sepsis renal failure; respiratory failure; pneumonia, atrial fibrillation, and ischemic stroke, the patient was placed on comfort care, and expired on pod#35.The preliminary cause of death was denoted as pneumonia; multiple organ failure contributed to the death.Per physician no allegation of device malfunction or product deficiency of the explanted valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.

Manufacturer Narrative

It was reported through additional information device not available for evaluation; was discarded.

Manufacturer Narrative

Manufacturer narrative: updated sections: h6 component codes, type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.Corrected data: d4 expiration date: apr 2, 2023 to feb 4, 2023.H4: feb 26, 2021 to feb 4, 2021.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12492928
• MDR Text Key: 272104289
• Report Number: 2015691-2021-05255
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)230204
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 11060A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 10/26/2021
• Supplement Dates FDA Received: 10/18/2021; 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 55 YR